FDA Adverse Event
Other
Summary report: N
DCA 2000 SYSTEM FOR HBA1C
MDR report key: 1112204
·
Received August 6, 2008
Report
- Report Number
- 1217157-2008-00009
- Event Type
- Other
- Date Received
- August 6, 2008
- Date of Event
- July 17, 2008
- Report Date
- July 18, 2008
- Manufacturer
- BAYER CORP.
- Product Code
- LCP
- PMA / PMN Number
- K951361
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER WAS PROVIDED INFORMATION REGARDING EXCHANGE OF UNIT FOR ANOTHER. A CORRECTIVE ACTION PLAN IS IN PLACE TO ADDRESS THIS ISSUE. THIS EVENT IS BEING REPORTED, BECAUSE IT OCCURRED IN A POTENTIALLY BIOHAZARDOUS ENVIRONMENT.
Description of Event or Problem · 1
CUSTOMER REPORTED SHE CUT HER FINGER WHILE TRYING TO REMOVE A CARTRIDGE THAT WAS STUCK IN THE DCA 2000 INSTRUMENT. CUSTOMER BANDAGED THE CUT AND SOUGHT NO FURTHER MEDICAL ATTENTION. SHE REPORTED THAT SHE WAS WEARING GLOVES AT THE TIME OF THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DCA 2000 SYSTEM FOR HBA1C | DCA 2000 SYSTEM FOR HBA1C | LCP | BAYER CORP. | 5031C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |